DEKA Research & Development · 3 days ago
Quality Engineer
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Responsibilities
Work cooperatively with cross functional design team members and project management to ensure compliance with applicable SOPs and regulations.
Participate in and lead Risk Management activities in accordance with ISO 14971.
Develop, implement, and approve Hazard Analyses, FMEAs, and other Risk Analysis documentation.
Lead investigations, identify root causes, implement corrective actions, and verify effectiveness through data analysis and problem-solving skills.
Coordinate individuals and teams performing investigations.
Provide guidance in Root Cause Analysis and CAPA based on manufacturing and medical device experience.
Identify and ensure compliance with applicable standards and regulations using engineering and technology expertise.
Accurately document information for communication with partners and regulatory bodies.
Prepare detailed work plans and procedures like Validation Plans.
Evaluate and approve proposed design or manufacturing process changes.
Drive system and process improvements, conduct reliability and statistical analysis, and participate in audits.
Qualification
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Required
Bachelor’s degree in an engineering or related STEM discipline. Additional training and experience may be considered in lieu of degree.
Minimum 2-5 yrs. of experience as QE in a regulated manufacturing environment.
Must be detail oriented and have strong communication both written and verbal.
Preferred
Experience with compliance, with applicable standards and regulations such as 21 CFR 820, ISO 13485, and ISO 14971 is preferred.
Company
DEKA Research & Development
DEKA Research & Development provides technology solutions for power, mobility, and water applications along with fluid management.
H1B Sponsorship
DEKA Research & Development has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (16)
2022 (16)
2021 (12)
2020 (14)
Funding
Current Stage
Late StageRecent News
Medical Device Network
2024-05-21
Company data provided by crunchbase